Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation

5 de mayo de 2022 actualizado por: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University

An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation

This study is a single arm, single center, prospective and open exploratory study.

About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：

  1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
  2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
  3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

15

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: yongxiang xia, doctor
  • Número de teléfono: 86-025-68303211
  • Correo electrónico: yx_xia@njmu.edu.cn

Ubicaciones de estudio

  • Porcelana
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210029
        • Jiangsu Province Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
  • have not received the first line of standard treatment or have received the first line of standard treatment failure;
  • at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
  • Child-Pugh class A or B (Child-Pugh score ≤7 );
  • adequate organ function;
  • a predicted life expectancy of at least 3 months.

Exclusion Criteria:

  • allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
  • receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
  • evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
  • uncontrolled pleural or peritoneal effusion;
  • pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
  • uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
  • hepatic encephalopathy;
  • Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
  • pregnant or lactating women or women contemplating pregnancy;
  • severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
  • esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Bevacizumab combine with FOLFOX4

Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：

  1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
  2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
  3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W Treatment will continue until disease progression, an unacceptable toxicity, or the patient voluntarily discontinues the study, whichever comes first.
Droga: Bevacizumab Biosimilar IBI305
Patients received bevacizumab and FOLFOX4 every two weeks
Otros nombres:
  • FOLFOX4

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (ORR) ,Based on RECIST 1.1
Periodo de tiempo: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST
Periodo de tiempo: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).
From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )
Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST
Periodo de tiempo: Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
the proportion of patients who achieved CR, PR, or SD as their best overall response
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)
Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST
Periodo de tiempo: DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years)
DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.
Overall Survival (OS)
Periodo de tiempo: From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )
Time-to Response (TTR) Based on RECIST1.1 and mRECIST
Periodo de tiempo: From date of first dose of study drug until CR or PR (up to approximately 2 years
TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST1.1 and mRECIST assessed by investigate.
From date of first dose of study drug until CR or PR (up to approximately 2 years
Objective Response Rate (ORR) ,Based on mRECIST
Periodo de tiempo: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis.
From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )
Safety as measured by number and grade of adverse events
Periodo de tiempo: From first dose until 30 days after the last dose (up to approximately 2 years )
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From first dose until 30 days after the last dose (up to approximately 2 years )

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The First Affiliated Hospital with Nanjing Medical University

Investigadores

  • Silla de estudio: Xuehao Wang, The First Affiliated Hospital with Nanjing Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de mayo de 2022

Finalización primaria (Anticipado)

31 de mayo de 2023

Finalización del estudio (Anticipado)

31 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2022

Primero enviado que cumplió con los criterios de control de calidad

26 de abril de 2022

Publicado por primera vez (Actual)

2 de mayo de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2021-SR-380

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir